Timely Access.  Affordable Treatment Options.  Better Outcomes.

Bowel Cancer Australia advocates for improved access to affordable treatment options.
 
While screening is important for the prevention and early detection of bowel cancer, it is also important for health policy to recognise that bowel cancer patients require improved access to affordable treatment options.
 
Bowel Cancer Australia welcomed the 2013 Coalition Government's commitment to restore transparency, certainty and confidence to the process by which medicines are listed on the Pharmaceutical Benefits Scheme (PBS) – ensuring medicines are listed on the basis of advice from the independent Pharmaceutical Benefits Advisory Committee.  
 
The Health Minister will have the authority to list medicines recommended by the PBAC that do not cost more than $20 million in any of the first four years of listing.  
 
The previous Labor Government changed PBS approvals (previously approved after a positive Pharmaceutical Benefits Advisory Committee (PBAC) recommendation) by requiring Cabinet approval.  Following pressure from industry groups and consumer organisations the Government began to automatically allow PBAC-approved treatments onto the PBS if they cost less than $10 million a year. 
 
Fewer than 40% of bowel cancers are currently detected early, which underscores the need for improved access to affordable treatment options.
 
Bowel Cancer Australia_Chemotherapy
 

Treatment Options 
 
Patients with advanced bowel cancer want to live as full a life as possible, for as long as possible, and will actively seek out new treatments.
 
Australians with advanced bowel cancer say they still have more they want to do with their lives and want access to new treatments to enable them to live as full a life as possible according to Bowel Cancer Australia's My Cancer My Voice Patient Survey.1

  • More than three quarters (77 per cent) said more life-extending treatments were needed for advanced bowel cancer;
  • If a new treatment was available overseas (but not in Australia), more than 40 per cent would travel overseas and a similar number (45 per cent) would write to the Government seeking access;
  • More than two thirds (68 per cent) would ask their doctor to try and get access to the treatment and about three in five (59 per cent) would try to get included in a clinical trial to access the treatment.

There are limited treatment options currently available to extend life for those with advanced bowel cancer.
 
A limited number of treatment options which have been shown to deliver modest incremental life-extending benefits are currently available in Australia for people with advanced bowel cancer.
 
Bowel cancer patients have had the longest wait for treatment funding, with one life-extending medication taking more than six years and a record eight submission before being subsidised.2
 
Despite this, median overall survival rates for people with advanced bowel cancer have increased over the last three decades from 5 months to 24 months,3 and in a select group of people (patients with KRAS wild type tumours) up to 33 months. 
 
 
Therapeutic progress in advanced (metastatic) bowel cancer

Bowel Cancer Australia Advocacy Therapeutic Progress
 
 

 
Developments - 2009 to 2015
 
2009

Avastin (bevacizumab) was added as a PBS-subsidised treatment, in combination with first-line chemotherapy, for patients with previously untreated metastatic bowel cancer with a WHO performance status of 0 or 1.  Avastin is also listed as a continuing PBS-subsidised treatment for patients who have previously received PBS-subsidised treatment with Avastin who do not have progressive disease and the treatment must be in combination with first-line chemotherapy.



2011
Erbitux (cetuximab) was added as a PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, for patients with a WHO performance status of 2 or less and with KRAS wild-type metastatic bowel cancer after failure of first-line chemotherapy.  The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.  Patients who have progressive disease on Vectibix (panitumumab) are not eligible to receive PBS-subsidised Erbitux. Patients who have developed intolerance to Vectibix of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised Erbitux.
 
Erbitux is also listed as a continuing PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, for patients who have received an initial authority prescription for Erbitux for treatment of KRAS wild-type metastatic bowel cancer after failure of first-line chemotherapy.  Patients must not have progressive disease and the treatment must be the sole PBS-subsidised anti-EGFR (Epidermal Growth Factor Receptor) antibody therapy for this condition.  Patients who have progressive disease on Vectibix are not eligible to receive PBS-subsidised Erbitux. Patients who have developed intolerance to Vectibix of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised Erbitux.
 
The PBS-subsidised treatment Xeloda (capecitabine) was extended to patients with stage III (Dukes C) colon cancer, following complete resection of the primary tumour in combination with another chemotherapy, Eloxatin (oxaliplatin) or as a monotherapy.  The combination therapy is known as XELOX
 
 
2012
KRAS mutation testing listed on the Medicare Benefits Schedule (MBS).
 
2013 The Pharmaceutical Benefits Advisory Committee (PBAC) rejected the submission to list Zaltrap (Aflibercept rch) as a PBS-subsidised treatment for patients with metastatic bowel cancer. 

2014
 
Vectibix (panitumumab) was added as a PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, for patients with a WHO performance status of 2 or less and with KRAS wild-type metastatic bowel cancer after failure of first-line chemotherapy.  The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.  Patients who have progressive disease on Erbitux are not eligible to receive PBS-subsidised Vectibix. Patients who have developed intolerance to Erbitux of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised Vectibix.
 
Vectibix is also listed as a continuing PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, for patients who have received an initial authority prescription for Vectibix for treatment of KRAS wild-type metastatic bowel cancer after failure of first-line chemotherapy.  Patients must not have progressive disease and the treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.  Patients who have progressive disease on Erbitux are not eligible to receive PBS-subsidised Vectibix.
 
Patients who have developed intolerance to Erbitux of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised Vectibix.
 
The Pharmaceutical Benefits Advisory Committee (PBAC) rejected the submission to list Stivarga (regorafenib) as a PBS-subsidised treatment for patients with metastatic bowel cancer. 
 
The Pharmaceutical Benefits Advisory Committee (PBAC) recommended that the current PBS restrictions for Vectibix (panitumumab) and Erbitux (cetuximab) be amended to urgently include only patients with RAS wild-type metastatic bowel cancer in coordination with corresponding amendments to the related MBS item descriptor to extend mutation testing to cover all RAS mutations.
 
The Pharmaceutical Benefits Advisory Committee (PBAC) rejected the submission to amend the current PBS restrictions for Vectibix (panitumumab) to include first-line treatment of patients with RAS wild-type metastatic bowel cancer.
 
The Pharmaceutical Benefits Advisory Committee (PBAC) recommended extending Erbitux's (cetuximab's) existing listing to include first-line treatment of metastatic bowel cancer.  The availability of first-line Erbitux on the PBS would increase choices of first-line treatment for patients with a RAS wild-type status.
 
The PBAC considered that the requested restriction should 1) include a note stating "Patient must not switch chemotherapy partners whilst maintaining an anti-EGFR antibody backbone in the face of progressive disease" in order to help prevent Erbitux being used beyond disease progression; 2) amend WHO performance status to be 1 or less; 3) limit use to a course of Erbitux for metastatic bowel cancer once in a life time (and allow a switch to Vectibix (panitumumab) during a course only according to the arrangements already in place for PBS subsidy of later-line therapy); 4) indicate anti-EGFR antibody and anti-VEGF antibody cannot be used at the same time.
   
2015 KRAS mutation testing on the Medical Benefits Schedule (MBS) amended to RAS mutation testing.
 
The PBS-subsidised listing for Erbitux (cetuximab) was amended to include treamtnet in combination with first-line chemotherpy of RAS wild-type metastatic bowel cancer patients who do not have progressive disease.
 
The PBS-subsidised listing for Avastin (bevacizumab) was amended to include treatment in combination with second-line chemotherapy for patients with RAS wild-type metastatic bowel cancer who have previously been treated with PBS-subsidised first-line anti-EGFR antibodies and who have not previously received PBS-subsidised treatment with Avastin for this condition, who have a WHO performance status of 0 or 1.  
 
The PBS-subsidised listing for Vectibix (panitumumab) was amended to include treamtnet in combination with first-line chemotherpy of RAS wild-type metastatic bowel cancer patients with a WHO performance of 0 or 1, who do not have progressive disease.
 
 
 
1. Stollznow. 2014. My Cancer My Voice Bowel Cancer Patient Survey. April 2014.
2. Wonder Drug Consulting. 2014. Reimbursement success rates and timelines for new medicines for cancer; and international comparison.  Available at http://medicinesaustralia.com.au/files/2013/07/140323_OIT_Wonder-Report_FINAL.pdf  
3. Vickers M (2013).  Slow and steady: incremental survival improvement in advanced colorectal cancer.  OE 2013: 12,1.
 
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